Tentative Approvals - February 2001
|
ANDA NUMBER |
DRUG NAME |
APPLICANT |
TENTATIVE APPROVAL DATE |
1 |
75-464 |
FLUOXETINE CAPSULES, USP 10 MG 20 MG |
APOTHECON INC. |
2/2/01 |
2 |
75-577 |
FLUOXETINE CAPSULES, USP 10 MG 20 MG |
ALPHAPHARM PTY. LTD. |
2/6/01 |
3 |
75-704 |
FAMOTIDINE TABLETS, USP 20 MG 40 MG |
MYLAN PHARMACEUTICALS, INC. |
2/6/01 |
4 |
75-708 |
FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ ML |
APOTHECON INC. |
2/7/01 |
5 |
75-797 |
TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) |
TEVA PHARMACEUTICALS USA |
2/14/01 |
6 |
75-709 |
FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
2/28/01 |
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